What predicts durable symptom relief of uterine fibroids treated with MRI-guided focused ultrasound? A multicenter trial in 8 academic centers.

OBJECTIVE: To identify variables predictive of durable clinical success after MRI-guided focused ultrasound (MRgFUS) treatment of uterine fibroids. MATERIALS AND METHODS: In this prospective, multicenter trial, 99 women with symptomatic uterine fibroids were treated using MRgFUS. Pelvic MRI was obtained at baseline and treatment day. The Uterine Fibroid Symptom-Quality of Life questionnaire was used to calculate a symptom severity score (SSS) at baseline and 6, 12, 24, and 36 months following treatment. Clinical, imaging, and treatment variables were correlated with symptom reduction sustained through the 12- and 24-month time points using univariable and multivariable logistic regression analyses. A novel parameter, the ratio of non-perfused volume to total fibroid load (NPV/TFL), was developed to determine association with durable outcomes. RESULTS: Post-treatment, mean symptom severity decreased at the 6-, 12-, 24-, and 36-month follow-ups (p < 0.001, all time points). In univariable analysis, three variables predicted treatment success (defined by ≥ 30-point improvement in SSS) sustained at both the 12-month and 24-month time points: increasing ratio of NPV/TFL (p = 0.002), decreasing total fibroid load (p = 0.04), and the absence of T2-weighted Funaki type 2 fibroids (p = 0.02). In multivariable analysis, the NPV/TFL was the sole predictor of durable clinical success (p = 0.01). Patients with ratios below 30% had less improvement in SSS and lacked durable clinical response compared with those between 30-79 (p = 0.03) and ≥ 80% (p = 0.01). CONCLUSION: Increased non-perfused volume relative to total fibroid volume was significantly associated with durable reduction of symptoms of abnormal uterine bleeding and bulk bother. CLINICAL RELEVANCE STATEMENT: Patient selection for sustained clinical benefit should emphasize those with likelihood of achieving high ablation ratios, as determined by imaging (e.g., device access, Funaki type) and by considering the total fibroid load, not just the primary symptomatic fibroid. TRIAL REGISTRATION: Clinical trial ID: NCT01285960. KEY POINTS: • Patient selection/treatment approach associated with durable symptom relief in MRI-guided focused ultrasound ablation of uterine fibroids remains unclear. • The ablation ratio, non-perfused volume/total fibroid volume, was positively associated with sustained symptom relief in both bleeding and bulk bother at 1- and 2-year follow-ups. • Selecting patients with imaging features that favor a high ratio of ablation to total fibroid load (including non-targeted fibroids) is the main factor in predicting durability of symptom relief after uterine fibroid treatment.

Pre-operative uterine artery embolization before hysterectomy or myomectomy: a single-center review of 53 patients.

PURPOSE: To assess outcomes of planned pre-operative uterine artery embolization (UAE) in patients with uterine fibroids at high risk for bleeding prior to hysterectomy or myomectomy. MATERIALS & METHODS: A retrospective review of 53 consecutive patients who underwent planned UAE followed by surgery from 2004 to 2019 was performed in a subset of patients deemed high risk for bleeding by the referring surgeon due to bulky fibroids and/or adhesions. Characteristics of the largest fibroid, total number of fibroids, embolic agents, estimated blood loss (EBL), complications, and other factors were collected. RESULTS: 53 patients (mean age = 41) had an elective UAE prior to a hysterectomy 24 (45%) or myomectomy 29 (55%). Median interval between UAE & surgery was 21.6 h (range 1.75 h-57 days). Of the myomectomies, 13 (45%) were open, 15 (52%) hysteroscopic and 1 laparoscopic. Mean number of fibroids/patient was 4.1 (SD 1.3), mean fibroid volume was 328 cm3 (range 11-741), and the mean fibroid diameter in longest dimension was 7.4 cm (range 3.2-15). Mean EBL was 90 (SD 99.5 mL). Three (10%) myomectomy patients required blood transfusion. All hysterectomies were via a laparotomy. Mean fibroid volume was 1699 cm3 (range 93-9099 cm3) with a mean maximum diameter of 16.2 cm (range 6.5-29.6) and an average of 2.4 (SD 1.7) fibroids. Mean EBL was 352 (SD 220 mL). Four (17%) hysterectomy patients required an intra- or post-operative blood transfusion. At a mean 1-year follow-up (range 1 month-14 years), 70% of UAE-myomectomy patients and 74% of UAE-hysterectomy patients reported symptom resolution. Three (6%) patients were readmitted: one for osteodiscitis, one wound dehiscence, and one for an infected retained fibroid after myomectomy. CONCLUSION: Planned pre-operative UAE resulted in intraoperative blood loss similar to "all-comer" myomectomy and hysterectomy patients in the literature. Further studies may elucidate which patients would be the best candidates for this staged treatment paradigm.

Fibromuscular dysplasia: A comprehensive review on evaluation and management and role for multidisciplinary comprehensive care and patient input model.

Fibromuscular dysplasia is a nonatherosclerotic, under-recognized disorder primarily seen in middle-aged women. It can lead to several complications, such as hypertension, headaches, dissections, aneurysms, myocardial infarctions, and cerebrovascular accidents, to name a few. This article provides a comprehensive review of current literature on epidemiology, etiology, diagnosis, treatment, and long-term surveillance and fibromuscular dysplasia management. In addition, it renders the role of education and prevention for patients living with this condition and family screening. Lastly, it emphasizes the importance of a comprehensive multidisciplinary care model and patient input, given the complexity of this disease and its systemic presence and protean manifestations.

Five-Year Outcomes From the United States Pivotal Trial of Valiant Captivia Stent Graft for Blunt Aortic Injury.

BACKGROUND: The Clinical PeRformancE of the Valiant Thoracic Stent Graft with Capitvia Delivery System for the EndovaSCUlar treatment of Blunt Thoracic Aortic Injuries (RESCUE) study evaluating thoracic endovascular repair using the Valiant Captivia endograft for blunt thoracic aortic injury reported promising 30-day outcomes. We now describe 5 years of follow-up of this cohort. METHODS: Fifty patients (mean age 40.7 ± 17.4 years, 76% male, mean injury severity score 38 ± 14.4) were treated for blunt thoracic aortic injury (2010 to 2012) with this endograft. Seventy percent (n = 35) of blunt thoracic aortic injury extent was grade III or higher. Extent of arch repair required full (40%) or partial (18%) left subclavian artery coverage. At 5 years, clinical and imaging compliance was 90.3% (28 of 31) and 67.7% (21 of 31), respectively. RESULTS: Thirty-day mortality was 8%. Three additional patients died of non-device-related causes (respiratory failure, infection, metastatic cancer) through 5-year follow-up, yielding a Kaplan-Meier survival of 85.2% through 5 years. Neither stroke nor spinal cord ischemia was observed at 5 years. Two type II endoleaks seen at 30 days resolved spontaneously, and no additional endoleaks were described in the study cohort through 5 years. No secondary endovascular procedures or conversion to open surgery were reported through 5 years. Four subjects underwent left subclavian revascularization for symptomatic indications. Finally, complete exclusion of the traumatic injury was maintained with no incidences of stent graft kinking, fracture, loss of patency, or migration through 5 years in all patients. CONCLUSIONS: This multicenter clinical trial describes excellent 5-year outcomes and durable exclusion of blunt thoracic aortic injury using a novel stent graft system. Thoracic endovascular repair with this endograft appears to be a safe and effective treatment option for patients with blunt thoracic aortic injury.

Acute lower gastrointestinal bleeding: predictive factors and clinical outcome for the patients who needed first-time mesenteric conventional angiography.

PURPOSE: We aimed to investigate patients with lower gastrointestinal bleeding who presented to the emergency department requiring initial conventional angiography. We report risk-stratified and mesenteric conventional angiography outcomes. METHODS: We retrospectively reviewed patients with lower gastrointestinal bleeding between 2001 and 2012. We included all consecutive patients with clinical lower gastrointestinal bleeding with a requirement of further angiography and possible embolization. Patients who had prior interventions or surgery were excluded. RESULTS: A total of 88 patients (35 women, 53 men) with a median age of 71 years (range, 23-99 years) were included in the analysis. Conventional angiography was positive and endovascular treatment was intended in 35 patients. Once the source of bleeding was found angiographically, endovascular treatment had a technical success rate of 90.3% and clinical success rate of 71.4%. Overall early rebleeding rate (<30 days) was 14.8% and late rebleeding rate (>30 days) was 13.6%. CONCLUSION: Identifying the source of lower gastrointestinal bleeding remains to be a clinical and angiographic challenge. Although we did not observe an association between mortality and clinical success, increased early rebleeding rates were associated with higher mortality rates.

Key Concepts in Critical Limb Ischemia: Selected Proceedings from the 2015 Vascular Interventional Advances Meeting.

Over 500,000 patients each year are diagnosed with critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI portends a grim prognosis; half the patients die from a cardiovascular cause within 5 years, a rate that is 5 times higher than a matched population without CLI. In 2014, the Centers for Medicare and Medicaid Services paid approximately $3.6 billion for claims submitted by hospitals for inpatient and outpatient care delivered to patients with CLI. Although significant advances in diagnosis, treatment, and follow-up of patients with CLI have been made, many challenges remain. In this article, we summarize selected presentations from the 2015 Vascular Interventional Advances Conference related to the modern demographics, diagnosis, and management of patients with CLI.

Management of Uterine Fibroids: A Focus on Uterine-sparing Interventional Techniques.

Uterine fibroids occur in approximately 50% of women over the age of 40 years, and an estimated 50% of those are symptomatic. Menorrhagia is the most common symptom and the primary indication for treatment, although bulk symptoms often occur and can be treated. Pharmacotherapy is typically inadequate unless it can be expected to successfully bridge to menopause or allow for a less-invasive intervention. However, hormonal therapies have risks. Hysterectomy is still the most commonly performed procedure for symptomatic fibroids and has the lowest rate of reintervention (compared with myomectomy or uterine artery embolization [UAE]), but rates of more serious complications are higher and patient satisfaction and ability to return to normal activities may also be less favorable. Myomectomy is not necessarily less morbid than hysterectomy and may have a greater failure rate than UAE. Techniques and devices vary with little standardization, and operator experience is crucial to success. The largest studies of UAE show very low rates of serious complications and rapid recovery. UAE significantly improves symptoms related to uterine fibroids in 85%-90% of patients. Herein, this article will discuss the nature of fibroids and their diagnosis, pharmacotherapy, surgical treatment, and nonsurgical interventional treatment, including UAE and magnetic resonance-guided focused ultrasound. (©) RSNA, 2016.

Multicenter clinical trial of the conformable stent graft for the treatment of acute, complicated type B dissection.

OBJECTIVE: The treatment of acute, complicated type B aortic dissection has evolved in the past several decades. Thoracic endovascular aortic repair when anatomy is suitable, has been regarded as the preferable treatment to seal the primary entry tear, redirect and re-establish adequate true lumen flow, and thereby promote aortic remodeling. This study was designed to determine the safety and efficacy of a conformable thoracic endoprosthesis device for patients with acute, complicated type B aortic dissection, defined as malperfusion or rupture or both. METHODS: Between January 2010 and January 2012, 50 patients with complicated type B aortic dissection from 26 sites in the United States were included in this prospective, multicenter, nonrandomized single-arm study. The primary safety end point was all-cause mortality through 30 days after treatment, and the primary efficacy end point was exclusion of the primary entry tear (Core Laboratory adjudicated) at 1-month follow-up. Secondary end points included false lumen thrombosis, dissection-based reintervention rate, and aortic rupture. RESULTS: All device implants were successfully completed. Six patients (12%) required additional device implantations ≤1 year from the index procedure. There was no conversion to open repair at 1 year. Exclusion of the primary entry tear at 30 days occurred in 97.5% of patients. All-cause mortality through 30 days was 8%. Survival was 88% at 1 year and 85% at 2 years. At 1 year after treatment, 35.1% of patients had experienced a decrease of ≥5 mm in overall diameter in the treated segment of the aorta. From pretreatment to the 36-month follow-up, the average minimum true lumen area increased by 206.3 mm(2), and the average maximum false lumen area decreased by 313.4 mm(2). The 30-day stroke rate was 18%; none were fatal, and one permanent deficit occurred. Four patients (8%) experienced spinal cord ischemia of any severity but without any permanent or significant deficits. New aortic dissection (3 retrograde, 2 de novo) occurred in five patients (10%). The secondary intervention rate was 18%. CONCLUSIONS: Treatment with the conformable thoracic endovascular aortic repair device produced favorable perioperative and intermediate level clinical and anatomic outcomes. In particular, an operative mortality of 8% in this cohort is comparable to that noted in a Society for Vascular Surgery objective performance criteria publication. Late survival in our cohort compares favorably with historical data referable to complicated type B dissection.

Anti-platelet and anti-hypertension medication use in patients with fibromuscular dysplasia: Results from the United States Registry for Fibromuscular Dysplasia.

Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular artery FMD involvement in isolation (OR=2.31, p<0.0001) or a history of previous intervention for FMD (OR=1.52, p=0.036). A greater number of anti-HTN medications was evident in isolated renal versus isolated cerebrovascular FMD patients. Factors associated with a greater number of anti-HTN medications were older age (OR=1.03 per year, p<0.0001), history of HTN (OR=24.04, p<0.0001), history of CAD (OR=2.71, p=0.0008) and a history of a previous therapeutic procedure (OR=1.72, p=0.001). In conclusion, in FMD, medication use varies based on vascular bed involvement. Isolated renal FMD patients receive more anti-HTN agents and there is greater anti-platelet agent use among patients with cerebrovascular FMD. Further studies correlating medication use in FMD with clinically meaningful patient outcomes are necessary.

Outcomes of Hypertensive Patients with Renal Fibromuscular Dysplasia Compared with Patients with Concomitant Atherosclerotic Renal Artery Stenosis following Endovascular Therapy.

PURPOSE: To examine if the outcomes after endovascular treatment in hypertensive patients with renal artery fibromuscular dysplasia (FMD) and incidental atherosclerotic renal artery stenosis (ARAS) differ from the outcomes in patients with FMD alone. MATERIALS AND METHODS: All cases of patients with renal artery FMD undergoing percutaneous transluminal angioplasty during the period 2002-2012 were reviewed. The patients with complete data before and after the procedure were identified (N = 84). Based on the procedural reports, these patients were separated into two cohorts: patients with isolated FMD (n = 59) and patients with concomitant atherosclerotic renal artery stenosis and FMD (ARAS-FMD) (n = 25). The medical record of each patient was reviewed for baseline blood pressure, antihypertensive medication use, and renal function data and the same data after the procedure. Procedural details including the angiographic findings, the number of stents placed, the average number of revascularization procedures, and the number of patients requiring more than one revascularization procedure were noted. RESULTS: The study population included 68 patients (FMD, n = 46; ARAS-FMD, n = 22). Patients in the FMD and ARAS-FMD cohorts experienced comparable significant decreases in systolic and mean arterial pressures after endovascular intervention. There was no change in the number of antihypertensive medications after the procedure within or between groups. Patients in the ARAS-FMD cohort had lower baseline estimated glomerular filtration rates (P = .007); however, renal function stabilized in both groups after endovascular therapy. CONCLUSIONS: Patients with ARAS-FMD respond to endovascular therapy with outcomes similar to patients with isolated renal artery FMD.

Managing mesenteric vasculitis.

Mesenteric vasculitis is a rare diagnosis, but it comprises a group of disorders that may have devastating manifestations. It is often difficult to diagnose using clinical symptoms and biomarkers. Vascular imaging often provides the best opportunity for the noninvasive diagnosis of vasculitis and obviates the need for performing a biopsy. The medical management of vasculitis involves controlling the inflammatory process with the use of steroids or other immunosuppressants, but medical therapy does not consistently provide regression of the vascular changes (ie, aneurysms or vascular occlusions) seen at the time of the initial diagnosis. Operative management remains the mainstay of therapy for focal occlusive or aneurysms, but the treatment options for multifocal disease remain challenging. Endovascular treatment is increasingly being used as a first line of treatment for symptomatic vasculitis. Interventionalists should be familiar with the indications and outcomes associated with the various therapeutic options for mesenteric vasculitis-associated occlusive disease and aneurysms.

Is fibromuscular dysplasia underdiagnosed? A comparison of the prevalence of FMD seen in CORAL trial participants versus a single institution population of renal donor candidates.

Renal artery fibromuscular dysplasia (FMD) may be underdiagnosed. We evaluated the prevalence of FMD in CORAL (Cardiovascular Outcomes in Renal Atherosclerotic Lesions) renal artery stent trial participants, in which FMD was an exclusion criterion for inclusion. We also evaluated the prevalence of FMD in a relatively healthy population of patients undergoing computed tomographic angiographic (CTA) screening for renal donor evaluation. All renal donor CTAs performed at our institution from January 2003 through November 2011 were retrospectively reviewed for the presence of FMD along with patient sex and age. These results were compared to angiographic core lab (ACL) findings for the CORAL trial. The CORAL ACL database contained 997 patients (mean age 69.3 years; 50% female). Fifty-eight (5.8%) CORAL trial patients (mean age 71.8 years; 75.9% female) demonstrated incidental FMD. The renal donor cohort included 220 patients (mean age 40.5 years; 64.5% female). Five (2.3%) demonstrated FMD (mean age 48.6 years; all female). The odds of FMD in the CORAL cohort were 2.65 times that seen in the renal donor cohort (95% CI: 1.12, 7.57). In C: onclusion, the 5.8% prevalence of renal artery FMD in the CORAL trial population, the presence of which was biased against, suggests underdiagnosis.

Driving change: taking ownership of our profession and its future.

The open-microphone sessions at the AMCLC provide a forum for the ACR's membership to be heard. The topics in 2013 included a review of the annual radiology workforce survey, the impact of teleradiology services, and the rationale for the new Imaging 3.0 initiative. Comments from members at the 2013 AMCLC unequivocally illustrated a single overarching theme: anxiety-anxiety about the future of our practices and anxiety about our profession. In light of recent and anticipated changes in health care, radiologists, radiation oncologists, interventional radiologists, nuclear medicine physicians, and medical physicists-members of the ACR-must continue to establish a leadership role in the health care system and serve as a cornerstone for all patient-care delivery models. ACR commissions, networks, institutes, and initiatives will position us for smoother transitions in the persistently altering health care landscape and will ensure that we have the expertise and tools to serve as leaders in health care systems and advocates for our patients in current and future health care systems.

Secondary procedures following thoracic aortic stent grafting in the first 3 years of the VALOR test and VALOR II trials.

PURPOSE: To compare the durability of thoracic endovascular aortic repair (TEVAR) in two similar clinical trials that used early- and later-generation stent grafts. MATERIALS AND METHODS: Secondary procedures from the prospective, nonrandomized, multicenter, clinical trial databases of the test arm of the VALOR and VALOR II trials were analyzed at 3 years. Descriptive and statistical analyses were employed to compare the rate of and potential predictors for secondary procedures. RESULTS: A total of 127 and 96 patients were available for a minimum of 3 years of follow-up in the test arm of VALOR and VALOR II, respectively. By the first year after the index procedure, VALOR II patients were significantly less likely to have undergone a secondary procedure versus patients in the test arm of VALOR (odds ratio [OR], 0.08; 95% confidence interval [CI], 0.01-0.63; P = .02), with most procedures performed for type I endoleak. Multivariate predictors at 3 years for the need for a secondary procedure in the VALOR test arm were maximum aneurysm diameter (P = .002) and aneurysm length (P = .01), both of which remained significant at the end of the study period. The estimated freedoms from secondary procedures in the VALOR test arm and VALOR II at 3 years were 85.1% (95% CI, 78.5%-89.8%) and 94.9% (95% CI, 88.8%-97.7%), respectively (P < .001). CONCLUSIONS: The rate of secondary procedures after TEVAR differed between the two cohorts, being substantially lower in the VALOR II trial at 1 year of follow-up. This finding suggests significant benefit from advances in some combination of operator experience, imaging systems, treatment planning, and device design.

The effect of balloon-occluded transvenous obliteration of gastric varices and gastrorenal shunts on the hepatic synthetic function: a comparison between Child-Pugh and model for end-stage liver disease scores.

PURPOSE: To evaluate the effect of balloon-occluded transvenous obliteration (BRTO) on the model for end-stage liver disease (MELD) and the Child-Pugh (C-P) score and their individual components. METHODS: A retrospective review of patients undergoing only BRTO without transjugular intrahepatic portosystemic shunt was performed (08, 2007 to 06, 2010). Pre- and post-BRTO MELD and C-P scores were calculated. The post-BRTO MELD and C-P score samplings were categorized as (1) immediate (within 14 days), (2) early (14-90 days), and (3) delayed (90-180 days) post-BRTO. The C-P and MELD scores and their individual components before and after (various sample intervals) were compared. RESULTS: A total of 29 consecutive successful BRTO procedures were found and assessed. In all, 26 had immediate post-BRTO sampling (average 1.8 days after BRTO), 13 (57%) had an early post-BRTO sampling (average 47 days from BRTO), and 10 (38%) had a delayed post-BRTO sampling (average 121 days from BRTO). The bilirubin rises significantly (P = .007) within days after BRTO, but synthetic function improves significantly between 1.5 and 4.0 months post-BRTO (international normalized ration: P = .02, bilirubin: P = .027, and albumin: P = .012). However, 31% (N = 8/ 26) of the patients had worsening ascites with or without hydrothorax. The MELD score significantly improved circa 4 months post-BRTO (from 14.1 to 10.7, P = .0008). However, the C-P score did not change significantly (from 7.6 to 6.7, P = .063). CONCLUSION: The BRTO has a positive effect on the hepatic synthetic function. However, there is a high incidence of post-BRTO ascites (31% of the patients). As a result, the MELD score appears to be a more sensitive gauge for hepatic synthetic function compared to the C-P score for patients undergoing BRTO.

Acute cor pulmonale and right heat failure complicating ethanol ablative therapy: anesthetic and radiologic considerations and management.

Ethanol is an effective ablative agent used for the treatment of certain solid organ tumors and vascular malformations (VMs). The egress of ethanol beyond the target tissue can be associated with significant changes to the cardiopulmonary system that can lead to cardiac arrest. This article reviews the contemporary role of ethanol in tumor and VM treatment and discusses the physiological mechanisms of acute pulmonary hypertension and cardiovascular collapse. The importance of periprocedural recognition of the hemodynamic changes that can occur with the use of ethanol and the treatment of this condition are discussed.